FDA Adverse Event
Malfunction
Summary report: N
GALLANT VR
MDR report key: 22026868
·
Received May 15, 2025
Report
- Report Number
- 2938836-2025-00004
- Event Type
- Malfunction
- Date Received
- May 15, 2025
- Date of Event
- April 28, 2025
- Report Date
- June 6, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05415067031990
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS SUPPLEMENTAL IS TO REPORT A CHANGE OF FDA REGISTRATION MANUFACTURING SITE INFORMATION FROM ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) 2938836 TO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2017865.
Additional Manufacturer Narrative · 0
D3 AND G1.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED INDICATED THE BLE ISSUE WAS RESOLVED VIA A SIMPLE INTERROGATION OF THE ICD. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH (BLE) TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390210 | GALLANT VR | NO MATCH | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CDVRA500Q | P000150578 | 05415067031990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |